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Rom, 2045BL

by Becker Orthopedic Appliance Company United States EUDAMED

Ref 2045B15Model 2045

EMDN Y061215

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number19454520457H Basic UDI-DIDate13 Jan 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
B3 Triple Axis Hip Joint
Model / Reference
2045, 2045B15
Primary DI / UDI-DI
00194545079895
Basic UDI-DI
19454520457H
EMDN Code
Y061215 Hip orthoses (including abduction orthoses)
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000004002
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Becker Orthopedic Appliance Company

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Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED fc7edccb-a749-4467-ad9d-ab8ad6fa2592 61 fields · synced 22 Oct 2026